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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K122450
Device Name MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS
Applicant
Mitsubishi Heavy Industries, Ltd.
4-6-22 Kan-On-Shin-Machi
Nishi-Ku
Hiroshima-Shi,  JP 733-8553
Applicant Contact YOICHI WAKIYAMA
Correspondent
Mitsubishi Heavy Industries, Ltd.
4-6-22 Kan-On-Shin-Machi
Nishi-Ku
Hiroshima-Shi,  JP 733-8553
Correspondent Contact YOICHI WAKIYAMA
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/13/2012
Decision Date 10/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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